Public awareness of heart disease is steadily
increasing. "Cholesterol" has become a layman's termhailed
as the ultimate evilwith few comprehending its true implications.
In fact, of individuals suffering from coronary artery disease,
an overwhelming 80% have normal cholesterol levels. Berkeley HeartLab,
Inc. (BHL) holds an exclusive license to procedures that elucidate
crucial details about blood cholesterol fractions. Working in conjunction
with personal physicians, Berkeley HeartLab provides thorough and
accurate assessments of cardiovascular health and personalized treatment
plans that provide long-term monitoring of patient progress.

More Than a Diagnostic

In 1978, Dr. Ronald Krauss of the Life Sciences
Division at Lawrence Berkeley National Laboratory began researching
cholesterol fractions and the cardiovascular risks associated with
these subtypes of low density lipoprotein (LDL) and high density
lipoprotein (HDL). Over twenty years later, in 1999, Krauss was
issued a patent for his work with cholesterol subclasses. This patented
technology currently serves as one of many diagnostics utilized
by BHL. Krauss' LDL-S3GGE; and HDL-S3GGE;
tests, developed at Lawrence Berkeley National Lab, are the only
methods available to analyze LDL and HDL distribution across all
scientifically known subclasses.

Lipoproteins carry cholesterol through
the bloodstream. Since cholesterol is a fatty substance
and blood is watery, mixing cholesterol and blood is similar
to combining oil and waterthe two substances simply
do not mix. To allow cholesterol to travel through the blood,
cholesterol is combined with a protein after it is generated
in the liverresulting in a fat and protein combination
known as a lipoprotein. These lipoprotein packages carry
the cholesterol, with each type of lipoprotein having a
unique role in heart disease risk. The aforementioned LDL
and HDL are just two kinds of lipoproteins. LDL is the primary
carrier of cholesterol through plasma, and is considered
to be "bad cholesterol."A high
LDL level is a positive risk factor for heart disease and
atherosclerosis. High density lipoprotein, or HDL, is the
so-called "good cholesterol." Raising the HDL to LDL ratio
has been shown to substantially lessen the risk of cardiovascular
disease.

LDL-S3GGE
is the most accurate separation of low density lipoproteins
(LDL). LDL cholesterol is the "bad" type of cholesterol
that can block arteries.

Traditional blood lipoprotein analysis measures
the levels of total cholesterol, LDL cholesterol, HDL cholesterol,
and triglycerides. Using the technology pioneered by Krauss, Berkeley
HeartLab breaks LDL and HDL into seven and five distinct categories,
respectively. Frank Ruderman, the company's Chairman and CEO, says
that Berkeley HeartLab has the "most discriminating technology for
breaking LDL and HDL into subclasses." Specific risks have been
associated with each of these individual subclasses, allowing BHL
to paint an extremely thorough and comprehensive picture of cardiovascular
health.

These lipoprotein measurements by no means stand
alone in Berkeley HeartLab's testing procedures. However, the lipid
analysis developed at Berkeley Lab is what Ruderman considers to
be the company's "raison d'être." Though it may represent
the fundamental core of the HeartLab's technology, inflammation,
clotting, genetics, inflammatory response, and a variety of other
factors are also addressed. When speaking of BHL, Ruderman is quick
to mention that the company "provides more than a diagnostic or
an assessment." He states that "Berkeley HeartLab participates in
advanced cardiovascular informatics." For each patienteach patient,
BHL examines all "causative agents" in heart disease risk and provides
personalized treatment programs including medication, diet, and
exercise that are monitored over time.

Combating All Odds

Initially, Krauss says that he "never thought
of the technology in terms of its commercial value." Krauss' tests
were originally used in a clinic affiliated with Sequoia Hospital,
located in Redwood City, California. In 1996, these efforts led
to the founding of Berkeley HeartLab in San Mateocontrary
to the location suggested by its name. Today, BHL has moved to Burlingame
and has a laboratory facility that operates out of Alameda.

In this startup's early days, a major obstacle
stood in its path: lipid subclasses comprised the linchpin of BHL's
testing, but the cardiology specialty had little knowledge about
the significance of these subclasses. Clinicians needed to understand
and embrace Berkeley Heart Labs analysis. In order to meet
this challenge, Ruderman says thatsays, "BHL spent millions
of dollars to educate cardiology specialists." Once the importance
of these subclasses was recognized, the HeartLab and its revolutionary
diagnostics gained respect throughout the medical field.

LDL-S3GGESubclass
Distribution.There are seven scientifically known LDL cholesterol
subclasses, known as LDL I, IIa, IIb, IIIa, IIIb, IVa, and
IVb. The subclasses of IIIa, IIIb, and IVb are made up of
smaller, more dense particles (shaded) are more closely related
to heart disease.

To date, Berkeley HeartLab has achieved an impressive
level of success. Its seventy-three employees are split approximately
evenly between the company headquarters and the laboratory site.
Ruderman states that the company is "growing in excess of 50% each
year." Dr. Krauss credits BHL's success to a "combination of the
technology's value and the ability to package it in a marketable
way to clinicians."

Making a Difference

Cardiovascular disease is the primary cause
of death among American adults. It kills one person a minute within
the United States.. Every twenty-nine seconds, an American suffers
from a coronary event. Berkeley HeartLab specifically targets what
Ruderman terms as "symptomatics," people who have a history of cardiovascular
problems. Here in the U.S., these individuals comprise a significant
portion of the adult population, including approximately nineteen
million individuals who could benefit from BHL diagnostics.

Recently, Berkeley HeartLab has had feature
articles in Esquire, Fortune, Men's Health, and
TIME. This coverage has heightened public interest in
BHL testing, and told inspiring tales of the HeartLab's treatments.
The March 19, 2001 issue of Fortune, shared the story
of Ira Lipman, the CEO of a large corporate security firm
who found he needed an emergency coronary bypass operation.
This bypass was particularly shocking to Lipman because he
had firmly adhered to the practices suggested by his doctor
to keep his lipid numbers within the normal range. Berkeley
HeartLab testing revealed that Lipman suffered from small
LDL particles, which can result in a 300% increase in heart
disease risk. Had Lipman received BHL's diagnostics and treatment
plan earlier, he might have eliminated his need for emergency
surgery.

The June 2001 issue of Men's Health tells
an equally impressive story. David Rubinson, a record producer for
such big-name stars as Carlos Santana, had undergone two coronary
bypass operations, even after following treatments prescribed by
physicians. Standard testing revealed little; Rubinson's lipid profile
was within the normal range. Berkeley HeartLab diagnostics uncovered
irregularities which conventional testing could not detect. With
BHL's help, Rubinson is now able to exercise control over his cardiovascular
condition. In a particularly memorable quote, the producer states
"When I talk about Superko [BHL's Medical Director], tears come
to my eyes Without this man, I'm gone."

Revolutionizing the Field

Ruderman describes Berkeley HeartLab's "founding
dream" as "improving cardiovascular treatment plans by providing
a more personalized approach." BHL's many satisfied patients will
affirm that this dream has been achieved. With the recent surge
of positive publicity, more and more patients are becoming interested
in Berkeley HeartLab. Insurance companies are also recognizing the
value of BHL tests and treatments; Medicare reimburses 30% of the
cost, PPOs reimburse from 80-90%, and contracts have been established
with several HMOs.

At the moment, their doctors refer the majority
of BHL patients. Nationwide, approximately 1000 doctors work with
Berkeley HeartLab, primarily in the states of Florida, Texas, and
California. These three states currently generate most of BHL's
revenue, as part of the company's regional rollout plan. The corporation
is actively raising funds to move beyond this triad of locations
and into other areas of the United States.

In addition to expanding the regions that are
served, Berkeley HeartLab is also increasing its research efforts
on the correlation between genomics and cardiovascular risk. In
conjunction with Roche, Ruderman states that BHL is examining the
links "between gene, phenotype, and physical outcome," hoping to
further "tailor treatment by looking at phenotypic subsets and genomic
correlation." These studies have the potential to significantly
impact the medical field and improve the lives of many.

Berkeley HeartLab is revolutionizing the treatment
of cardiovascular disorders. As the business grows, BHL's impact
can only increase. We have high hopes that the HeartLab's personalized
treatment will soon become the norm in the field of cardiovascular
medicine.